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A Screening Strategy for Q Fever Among Pregnant Women

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ClinicalTrials.gov Identifier: NCT01095328
Recruitment Status : Unknown
Verified February 2010 by University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : March 30, 2010
Last Update Posted : July 1, 2010
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
University Medical Center Groningen

Study Description
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Brief Summary:

Q fever in the Netherlands is becoming more common. A Q fever infection is a serious threat to certain risk groups,including pregnant women. Pregnant women are more often than the general population asymptomatic. Studies from France show that an infection with Coxiella burnetii may cause obstetric complications including spontaneous abortion, intrauterine fetal death, intrauterine growth retardation and oligohydramnios.

The aim of this study is to assess the effectiveness and cost effectiveness of a multidisciplinary screening program, whereby pregnant women in first line healthcare in high-risk areas for Q fever are screened with a single blood sample during pregnancy. If found positive for Q fever, advise for antibiotic treatment will follow as part of regular healthcare. Treatment is therefore not part of the study protocol.

The results of this study will give more insights in the risks of asymptomatic Q fever in pregnancy and the benefits and harms of a screening strategy during pregnancy. This study will be used to give an evidence based advice to the Dutch minister of health on screening for Q fever in pregnancy.


Condition or disease Intervention/treatment Phase
Q Fever Other: screening Not Applicable

Detailed Description:

We will conduct a clustered randomized controlled trial among pregnant women within an area of high transmission. The study participants will be recruited by the midwives in high risk areas, defined by postal code from the RIVM. To inform the public in this area about the study we will publish an article in local newspapers. The midwife centers will be randomized to recruit pregnant women for either the control group or the intervention group. The pregnant women will receive study information by mail using the midwives patients file. It is estimated that approximately 10,000 eligible women live in the areas of transmission. After written informed consent, they will start with the strategy for which the midwife center is randomized.

Participants will be asked for a blood sample in their second trimester of pregnancy, possibly combined with the routine structural ultrasound around 20 weeks of pregnancy to minimize hospital visit. If participants are enrolled in their third trimester, they will have their blood sampling as soon as possible after inclusion.

When taking part in the intervention group the sample will be tested immediately for Q fever. If found positive for acute or chronic Q fever, patients have to be referred, according to local protocol, to a hospital for further pregnancy monitoring and long-term bacteriostatic treatment. Follow-up blood samples are required at 14 days, 3, 6 and 12 months after the first blood sampling as part of the standardized control of Q fever disease to diagnose possible chronicity of infection. Furthermore, current routine for pregnant women being treated with antibiotics against Q fever is to perform monthly blood analyses to monitor treatment, and if the serological parameters descend, these controls are brought back to once every two months. According to local protocol patients with Q fever have to deliver in hospital. After pregnancy serology should be continued with check-ups at 3, 6 and 12 months following the current protocol. Furthermore, after delivery a bacteriocide treatment with doxycycline or an alternative will be started by the specialist as part of regular health care.

In the control arm the blood samples will be stored, and analyzed for Q fever after delivery. If tested positive for Q fever after pregnancy antibiotics could be started if needed as part of regular health care.

At baseline, a questionnaire will be administered to all participants asking about the current pregnancy , pregnancy outcome of any previous pregnancies and demographics. Further risk factors for pregnancy outcome will also be obtained such as smoking and drinking behavior, risk-elevating comorbidities and medication use.

After delivery all relevant outcome data will be collected by questionnaires filled out by the midwife, GP or specialist after delivery, notably the presence of obstetric complications. One month after delivery or end of pregnancy, a last questionnaire will be administered to the participant to verify potential long-term consequences of Q fever, potential loss of income, health-related quality-of-life, fatigue and depressive symptoms. Furthermore questions will be asked about the condition of the newborn and risk-accessing questions for Q fever infection will be asked.

In the context of the secondary research questions an extra blood sample will be required, and placentas as well as amniotic fluid will be collected after delivery. The latter will only take place in a limited number of women and only if they gave birth in a hospital.

All participants will receive usual care and will be asked to visit the general practitioner if symptoms of Q fever occur. He/she will start diagnostic research and treatment or will refer the patient to the hospital. Furthermore, both arms have access to an expert team for support.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Cost-effectiveness of a Screening Strategy for Q Fever Among Pregnant Women in Risk Areas: a Clustered Randomized Controlled Trial
Study Start Date : March 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: intervention
Screening for Q-fever during pregnancy
 Other: screening
screening for Q-fever with a single blood sampling
No Intervention: control
No screening for Q-fever during pregnancy
 Other: screening
screening for Q-fever with a single blood sampling


Outcome Measures
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Primary Outcome Measures :
  1. obstetric or maternal complications in Q fever positive women [ Time Frame: obstetric complications till delivery, maternal till one month post partum ]
    Presence of any obstetric or maternal complication after the first trimester of pregnancy, i.e. spontaneous abortion, intrauterine fetal death, termination of pregnancy, oligohydramnios, premature delivery or intrauterine growth retardation. Spontaneous abortion is defined as spontaneous expulsion of the embryo or the fetus before 16 weeks of gestation. Oligohydramnios is defined as the ultrasonic measurement with an amniotic index <=5 cm. IUGR is defined as a fetal birth weight less than the 10th percentile for gestational age, according to the national reference curves.


Secondary Outcome Measures :
  1. course of infection in pregnant women [ Time Frame: till one month post partum ]
    maternal chronic infection or reactivation

  2. the accuracy of the diagnostic tests used for screening [ Time Frame: around 20 weeks of gestation ]
    the accuracy of the diagnostic tests used for screening (serology vs PCR)

  3. placentitis [ Time Frame: one month post partum ]
    the extent to which the placenta has been infected

  4. costs [ Time Frame: till one month post partum ]
    The costs associated with health care consumption and other related costs among pregnant women.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • being pregnant under first line healthcare
  • being eighteen years or older
  • having signed an informed consent form
  • having a estimated date of delivery between June 1th 2010 en December 31th 2010

Exclusion Criteria:

  • unable to fulfill study procedures
  • absence of informed consent
  • have been tested positive for Q fever prior to pregnancy
  • unable to understand Dutch
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095328


Contacts
Contact: Eelko Hak, Dr +31 50 36 14616 E.Hak@epi.umcg.nl
Contact: Janna M Munster, MD, MSc +31 626890978 J.Munster@og.umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Janna Munster, MD, MSc    +31 626890978    J.Munster@og.umcg.nl   
Contact: Eelko Hak, Dr.    +31 50 36 14616    E.Hak@epi.umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Eelko Hak, Dr. University Medical Center Groningen
Principal Investigator: Janna Munster, MD, MSc University Medical Center Groningen
Principal Investigator: Wim van der Hoek, Drs. Center for Infectious Disease Control
Study Chair: Ronald Stolk, Prof. dr. University Medical Center Groningen
Principal Investigator: Jan Aarnoudse, Prof. dr. University Medical Center Groningen
Principal Investigator: Sander Leenders, Dr. Jeroen Bosch Hospital
Principal Investigator: Bert Timmer, Dr. University Medical Center Groningen
More Information
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Publications:
Advice Dutch Health Council, http://www.gezondheidsraad.nl/nl/adviezen/briefadviesbijeenkomst- over-q-koorts-nederland
Meekelenkamp JCE, Notermans DW, Rietveld A, Marcelis JH, Schimmer B, Reimerink JHJ, Vollebergh JHA, Wijkmans CJ, Leenders ACAP. Seroprevalence of Coxiella burnetii in pregnant women in the province of Noord-Brabant in 2007. Infectieziekten Bulletin, 20: 57-61 [in Dutch].

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. E. Hak, Epidemiology, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01095328     History of Changes
Other Study ID Numbers: NL30340.042.09
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: February 2010

Keywords provided by University Medical Center Groningen:
Q fever
Pregnancy
Screening
Cost-effectiveness

Additional relevant MeSH terms:
Fever
Q Fever
Body Temperature Changes
 Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections